Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Not Applicable

• Conditions: Subluxation of Lens; Surgical Instruments，Cataract

• Registration Number: NCT04062084
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2019-09-01
• Status Verified: 2020-12
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of lens subluxation.
• Patients need to undergo lens subluxation surgery

Exclusion Criteria

• Active intraocular inflammation
• The intraocular pressure (IOP) was higher than 25 mmHg
• The endothelial cell count (ECC) was less than 1,200 cells/mm2
• Combined with other eye diseases
• Combined with other serious systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical success rate	through study completion, an average of 1 year	Surgical success rate of operation with different retractor

Secondary Outcome Measures

Name	Time	Method
Successful implantation rate of intraocular lens	through study completion, an average of 1 year	implantation rate of intraocular lens with different retractor
Visual function	1day postoperation，1 week，1 month， 3month postoperation	Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart
intraocular pressure	1 day, 1 week, 1 month, and 3 month postoperation	intraocular pressure
endothelial cell count	1 week, 1 month, and 3 month postoperation	endothelial cell count

Trial Locations

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China